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Keywords:

  • diabetes;
  • diabetic foot;
  • PTA;
  • treatment;
  • endovascular

Summary

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Diabetic foot ulceration (DFU) is recognized as one of the most serious complications of diabetes. Active revascularisation plays a crucial role in achieving ulcer healing. Non-surgical, minimally invasive, revascularisation options for DFU have expanded over the last decade and have become a prominent tool to prevent amputation. Endovascular treatment of arterial DFU lesions is mainly concentrated in the below-the-knee arteries. The outcome of both open surgery and endovascular treatment is broadly spoken the same for the endpoints ulcer healing and limb salvage and is between 78% and 85%. The choice between endovascular treatment and open surgery should always be the outcome of a team discussion. Local expertise plays an important role in these discussions. In many institutions, the endovascular approach has currently become the first choice treatment option. The revascularisation of below-the-knee vessels needs experienced hands, team discussion and the right set of devices. Centralisation in DFU centres is therefore probably the best guaranty for the best outcome. Copyright © 2012 John Wiley & Sons, Ltd.


Introduction

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Diabetic foot ulceration (DFU) is recognized as one of the most serious complications of diabetes. About 5% off all patients with type 2 diabetes will develop an arterial DFU problem. Up to 70% of all lower-leg amputations are performed in patients with diabetes, and up to 85% of all amputations are preceded by an ulcer [1, 2]. Ulcer prevention is therefore recognized to be the best way to prevent amputation. However, when an ulcer is present, the primary need is to achieve ulcer healing. If there is also concomitant infection, ulcer healing is often more difficult. Optimal wound care, antibiotics, off-loading and other techniques should all be applied in daily practice to achieve ulcer healing. Active revascularisation plays a crucial role in achieving ulcer healing. Non-surgical revascularisation options for DFU have expanded over the last decade and have become a prominent tool to prevent amputation [3, 4].

Aetiology of DFU

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

An ischaemic or neuroischaemic DFU is very often not caused by an acute or semi-acute arterial occlusion but by a distortion of the, often long-time existing, equilibrium between poor blood inflow due to vessel disease and low demand. The vascular disease in diabetic patients is mostly localized in the lower-leg arteries. Iliac arteries and superficial femoral arteries can also be diseased, but this is rare (<10%) and is always seen in combination with extensive below-the-knee (BTK) disease [5]. The pattern of arterial involvement in the lower-limb arteries in diabetes is also typical and different from atherosclerosis. Diabetic arterial disease often shows long segmental occlusions while atherosclerosis often shows short focal lesions [5]. The calcifications in diabetes are typical media sclerosis while the calcifications in atherosclerosis are diffuse intimal. Also, there is often less disease in the foot arteries in diabetes while in atherosclerosis the disease is often more pronounced in the foot with subsequent less endovascular options due to very poor outflow.

Diabetic foot lesions are often pain free because of the accompanying neuropathy while rest pain and painful ulcers are almost always seen in atherosclerosis. The combination of rest pain and an ulcer can be seen on DFU, but this is less common.

When one accepts the concept that disease in DFU problems is long-standing and that a misbalance of the equilibrium between the inflow of blood and the oxygen demand in the DFU needs to be restored, the conception of how to treat these patients is different from the treatment of atherosclerosis. It is the small skin lesion in a DFU that will increase the demand for oxygen and thereby unbalance the existing equilibrium leading to a relative shortage of blood and oxygen needed for normal skin healing. Infection worsens this condition by further increase of blood demand due to the increased metabolism in the wound.

To reverse this cycle, an increase in inflow of blood to the lesion era is needed just to support skin healing. Of course, all other supportive measurement for optimal wound care should also be taken. Revascularisation is by no means a stand-alone procedure. Crucial is (temporary) increase in blood flow to the lesion era to support ulcer healing. That is why some have started to call this treatment for DFU's a ‘temporary percutaneous bypass’ [6]. When the lesion is cured, the skin closed, the extra blood supply is no longer needed to keep the skin intact. That is why limb salvage is always reported much higher than the patency of the recanalization.

Percutaneous techniques are minimally invasive and can be performed under local anaesthesia. This makes these techniques very applicable for these often old and fragile patients.

Every patient with a DFU should be investigated for peripheral arterial disease (PAD). A simple test-like palpation of the peripheral pulses is often enough to rule out PAD. If there is uncertainty, an ankle/brachial index <0.9 is suspect for PAD.

The traditional non-invasive parameters for critical ischaemia, such as ankle and toe pressure and transcutaneous oxygen, are of less value in diabetic patients. Only if revascularisation is considered, diagnostic imaging is required.

Diagnostic imaging

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Duplex Doppler, computed tomography angiography (CTA) and magnetic resonance angiography (MRA) all have their specific advantages and disadvantages. CTA and MRA, however, have never been compared in critical ischaemia patients with a DFU and PAD. Local expertise is very important in making a choice. The sensitivity of both CTA and MRA is high compared with the lower sensitivity of duplex.

Diagnostic angiography should only be performed in combination with a percutaneous intervention. However, the threshold for doing angiography should be low in diabetic patients with an ulcer as optimal and fast intervention is always needed, to prevent the rapid deterioration with subsequent amputation.

Treatment options

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

There are four treatment options: conservative treatment, primary amputation, surgical bypass and endovascular revascularisation. The choice for any of these treatment options has to be made in a multidisciplinary team. The choice between surgical and endovascular treatments is made on the local anatomy, patient condition and the local expertise.

Endovascular treatment

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Endovascular treatment of (neuro)ischaemic DFU's is mainly concentrated in the BTK arteries [5]. Iliac and femoropopliteal lesions are also sometimes seen in diabetic patients but are a minority. It is even doubtful whether these lesions are not mainly associated atherosclerotic lesions. To discuss endovascular treatment, we should focus on treating BTK lesions. Diabetic lesions are often long segmental lesions while atherosclerotic lesions are more often short [5].

Treating long segmental diabetic lesions requires a dedicated centre with ample experience because these kinds of treatments need a personalized approach. Each procedure is tailored to the patient's needs, possibilities and clinical situation. Endovascular treatment should only be performed in dedicated centres. The endpoint of the treatment is ulcer healing and, in the same token, limb salvage.

Indications for treatment

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Non-healing ulcers with or without infection and gangrene are the indications for percutaneous revascularisation. The inclusion is, however, that the limb is still viable and that the treatment will contribute to the quality of life. A bedridden patient with dementia is therefore not a primary candidate for percutaneous revascularisation. However, if the patient already had an amputation of the other leg, the limb now at risk can be essential for transfer to facilitate nursing. Again, showing how important a multidisciplinary team, including nurses, is for decision making.

Also, the choice between endovascular treatment and open surgery is often the outcome of a team discussion. Local expertise plays an important role in these discussions. High risk for surgery, non-availability of good venous material for a conduit, no segments for surgical anastomoses or poor outflow are often additional reasons to choose for an endovascular solution. But in many institutions, the endovascular approach is currently the first choice treatment option [7-9]. The understanding that in diabetic patients ‘time is tissue’ has the consequence that treatment of an infected ulcer in diabetic patients should be handled as an emergency procedure, to be dealt with preferable within 24 h.

Endovascular

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Endovascular treatment is preferably performed, after local anaesthesia, by direct antegrade puncture in the common femoral artery of the limb at risk. After angiography of the lower-limb and foot arteries in two directions, anteroposterior and lateral, a treatment plan is made. Length or number of the occlusions or calcifications is not of major importance in experienced endovascular hands. However, outflow arteries should preferably be available although revascularisation to a collateral can be performed. For the patency of the procedure, the outflow is very important; and therefore, the extension of a revascularisation to the pedal arch and beyond, passing this pedal arch, can be important to create such an outflow. The latter is only to be performed by very experienced hands. Straight-line pulsatile flow to the foot is the most optimal outcome, but if this is not possible, other solutions should be looked for. There are no specific morphological guidelines to decide for endovascular treatment; basically, most lesions can be treated with an endovascular approach. This is different from surgery where a suitable anatomy is mandatory. The armamentarium to treat these often complex lesions has changed considerably over the last years, and dedicated and sophisticated materials have been brought to the market. Without access to this new armamentarium, BKT interventions are not possible anymore. Everybody performing BTK treatment in critical ischaemia and diabetic patients should try to build his or her own set of tools that work for him or her and not go with the fashion of the day.

Preferably, the artery supplying the ulcer region should be revascularized; however, opening up collateral pathways can sometimes be enough to obtain good clinical success. The theory of so called ‘angiosomes’, specific arteries that supply very well described areas in the foot, has gained much attention recently [10]. One has to realize that these angiosomes are, first and foremost, a representation of normal anatomy in non-diseased vessels. How far this will be also true in the DFU is not clear.

Endovascular technique

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

Endovascular technique such as crural revascularisation is a specialized technique that should only performed after ample training, extensive experience and enough patient volume to keep a certain skill level. Procedures are performed by antegrade puncture; over the bifurcation approach should never be performed. In the BTK vessels, simple balloon angioplasty most often works fine; only in rare cases where prolonged low pressure inflation does not produce good flow to the foot, a stent option might be considered. Because we are not aiming for long-term patency, primary stenting should not be performed. Also, stenting might block a repeat intervention, if necessary. In DFU lesions, stenting is even less desirable because the lesions are often long and not focal, compared with atherosclerosis, which would implement using very long stents. For the latter, there is currently no evidence for BTK interventions. A normal crural vessel is anything between 2.5 and 3 mm until the ankle, beyond it is 2–1.5 mm. In a crural vessel with some media calcinosis, a 3-mm long balloon often shows the best result. Long balloons are very helpful to treat long lesions, as the old saying ‘procedure time is complication time’ is still true. Good inflation is only obtained with an inflation device in these long balloons.

There is a wide discussion about how many vessels should be treated. A recent article [11] showed that there is a relation between more vessels and better outcome. As diabetic crural lesions can often be very firm and difficult to pass, the use of more rigid 0.35 wires and balloons with a high pushability should certainly not be abandoned for BTK treatment. Especially in patients with also end-stage renal disease, the crural vessels can sometimes even be too rigid to pass a wire or a percutaneous transluminal angioplasty balloon.

One of the problems in BTK interventions is spasm. Rigorous use of spasmolytics is therefore very important. Spasm can show a misleading picture of failure and should therefore be recognized. Time will cure all spasm, and 24-h heparinization after crural treatment with spasm can often also solve the problem.

Complications after endovascular treatment are in the range of about 7–17% while mortality is very low. Most complications are local groin haematomas.

New revascularisation devices

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

There are many new or revitalized devices on the market for BTK treatment: laser, cryoplasty, drug-eluting stents and balloons, special-designed low-profile stents and bio-absorbable stents. There is currently no evidence of substantial power to promote any of these devices in the treatment of DFU.

Transluminal or subintimal

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

How to recanalize the vessel, either through the lumen or through the vessel wall (subintimal), is always a point of debate. If transluminal is possible, this route should be taken; however, if not, the subintimal route can also be chosen in crural vessels. Subintimal results are shown to be very good [12]. Beyond the level of the ankle, going into the foot, subintimal angioplasty has worse outcome, but evidence for this is only anecdotal. For subintimal recanalization, one has to increase the balloon inflation time, sometimes up to 2 min. Both transluminal and subintimal routes can be treated again if needed.

Outcome endovascular treatment

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

The outcome of both open surgery and endovascular treatment is broadly spoken the same for the endpoints ulcer healing and limb salvage and is between 78% and 85% [13-15]. The patency of a bypass surgery is, however, reported to be better than that of an endovascular treatment. This is not a major issue for consideration because ulcer healing with subsequent limb salvage almost always takes place in a period within 6–9 months. Any patency beyond ulcer healing is often not needed because these diabetic patients mostly do not suffer from rest pain. An endovascular intervention normally has a patency that is enough to obtain the final goal of ulcer healing. That is why limb salvage after an endovascular treatment is always reported to be 20% higher than actual patency. This is why an endovascular revascularisation in a critical ischaemic foot is referred to as ‘temporary’ bypass [16].

Conclusion

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References

There are many technical innovations in an endovascular treatment of BTK arteries in diabetic patients with an ulcer, all aiming at ulcer healing and limb salvage. As discussed earlier, the patency is not a primary issue as long as it does not fall below the range of about 6 months. Most new techniques have not been proven in any clinical trial to improve the already very high percentage of ulcer healing or of limb salvage after plain old balloon angioplasty. For the time being, the extra costs of these new devices are often not justified. However, devices to overcome revascularisation hurdles such as calcifications, especially the media calcinosis in diabetic patients, can be very helpful in achieving the best results. Revascularisation of crural vessels needs experienced hands, team discussion and the right set of devices. Centralization in DFU centres is therefore probably the best guaranty for the best outcome.

References

  1. Top of page
  2. Summary
  3. Introduction
  4. Aetiology of DFU
  5. Diagnostic imaging
  6. Treatment options
  7. Endovascular treatment
  8. Indications for treatment
  9. Endovascular
  10. Endovascular technique
  11. New revascularisation devices
  12. Transluminal or subintimal
  13. Outcome endovascular treatment
  14. Conclusion
  15. Conflict of interest
  16. References
  • 1
    Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on between individuals with and without peripheral vascular disease. The EURODIALE study. Diabetologia 2008; 51: 747755.
  • 2
    Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot? Diabetes Metab Res Rev 2000; 16(Suppl 1): S75S83.
  • 3
    Faglia E, Mantero M, Caminiti M, et al. Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects. J Intern Med 2002; 252: 225232.
  • 4
    Jacqueminet S, Hartemann-Heurtier A, Izzillo R, et al. Percutaneous transluminal angioplasty in severe diabetic foot ischemia: outcomes and prognostic factors. Diabetes Metab 2005; 31: 370375.
  • 5
    Graziani L, Silvestro A, Bertone V, et al. Vascular involvement in diabetic subjects with ischemic foot ulcer: a new morphologic categorization of disease severity. Eur J Vasc Endovasc Surg 2007; 33(4): 453460.
  • 6
    Reekers JA. Percutaneous intentional extraluminal (subintimal) revascularization (PIER) for critical lower limb ischemia: too good to be true? J Endovasc Ther 2002; 9(4): 419421.
  • 7
    Faglia E, Dalla Paola L, Clerici G, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg 2005; 29(6): 620627.
  • 8
    Jämsén T, Manninen H, Tulla H, Matsi P. The final outcome of primary infrainguinal percutaneous transluminal angioplasty in 100 consecutive patients with chronic critical limb ischemia. J Vasc Interv Radiol 2002; 13(5): 455463.
  • 9
    Uccioli L, Gandini R, Giurato L, et al. Long-term outcomes of diabetic patients with critical limb ischaemia followed in a tertiary referral diabetic foot clinic. Diabetes Care 2010; 33(5): 977982.
  • 10
    Alexandrescu V, Vincent G, Azdad K, et al. A reliable approach to diabetic neuroischemic foot wounds: below-the-knee angiosome-oriented angioplasty. J Endovasc Ther 2011; 18(3): 376387.
  • 11
    Peregrin JH, Koznar B, Kovác J, et al. PTA of infrapopliteal arteries: long-term clinical follow-up and analysis of factors influencing clinical outcome. Cardiovasc Intervent Radiol 2010; 33(4): 720725.
  • 12
    Met R, Van Lienden KP, Koelemay MJ, Bipat S, Legemate DA, Reekers JA. Subintimal angioplasty for peripheral arterial occlusive disease: a systematic review. Cardiovasc Intervent Radiol 2008; 31(4): 687697.
  • 13
    Ferraresi R, Centola M, Ferlini M, et al. Long-term outcomes after angioplasty of isolated, below-the-knee arteries in diabetic patients with critical limb ischaemia. Eur J Vasc Endovasc Surg 2009; 37(3): 336342.
  • 14
    Hering J, Angelkort B, Keck N, Wilde J, Amann B. Long-term outcome of successful percutaneous transluminal angioplasty of the fibular artery in diabetic foot syndrome and single-vessel calf perfusion depends on doppler wave pattern at the forefoot. Vasa 2010; 39(1): 6775.
  • 15
    Werneck CC, Lindsay TF. Tibial angioplasty for limb salvage in high-risk patients and cost analysis. Ann Vasc Surg 2009; 23(5): 554559.
  • 16
    Reekers JA. The feasibility of a percutaneous temporary pedal bypass. Eur J Vasc Endovasc Surg. 2007; 34(1): 5052.